Overview
Facilitates the efficient purification of therapeutic antibodies
Antibodies are recognized as promising next-generation therapeutics. However, their purification processes remain a major cost driver in production.
TerpSep™ is a hollow fiber membrane developed by integrating Otsuka Chemical’s precision polymer synthesis and polymerization technologies with Toyobo’s expertise in microfabrication and film-formation.
The lineup features both "charged purification membranes" and "virus removal membranes," contributing to the optimization of purification workflows.
Toyobo’s hollow fiber membrane technology
Toyobo has built up extensive experience as a hollow fiber membrane supplier since the 1980s.
Precise pore size control enables both efficient virus capture and selective permeation of target components. The asymmetric gradient pore structure of the membrane, extending from the inner to outer layers, effectively minimizes membrane fouling.
Product Inquiries
Contact UsCharged membranes
(TerpSep™-A, TerpSep™-C)
Charged purification membranes — a new purification process serving as an alternative to column chromatography
A specialized polymer with a high adsorption affinity for charged substances, combined with the inherent separation performance of hollow fiber membranes, allows simultaneous impurity removal and efficient purification of target proteins, including antibodies.
Comparison with conventional column chromatography
Conventional bead-based column chromatography requires sequential antibody binding, washing, and elution steps. In contrast, TerpSep™ hollow fiber membranes enable purification via a simple flow-through mode, significantly streamlining the process and reducing its operational complexity. This method eliminates the need to install large-scale cleaning systems and wastewater treatment facilities, thereby enabling a more compact equipment footprint.
Conventional column chromatography
Purification with TerpSep™-A/C
*The illustration depicts TerpSep™-A. TerpSep™-C employs a comparable mechanism to remove cationic components.
| Conventional column chromatography | Purification with TerpSep™-A/C | |
| Multi-step | Operation | Simple |
| Necessary | Eluent | Not required |
| Long | Process time | Short |
| Not available | Continuous purification | Available |
Product comparison
| Existing products | Conventional hollow fiber membrane | TerpSep™ A/C |
|
|---|---|---|---|
| Ion exchange chromatography | |||
| Processing speed | × | ○ | ○ |
| Removal performance | ○ | × | ○ |
| Ease of operation | △ | ○ | ○ |
Product lineup
■ TerpSep™-A
TerpSep™-A incorporates a cationic polymer uniformly throughout the membrane, facilitating the adsorption and effective capture of anionic components while preserving the size-based separation functionality.
Adsorption test result for an anionic dye
The cationic polymer is uniformly distributed throughout the membrane, enabling adsorption across the entire membrane.
HCP (Host Cell Protein) removal
Albumin adsorption
Anionic charged proteins can be adsorbed and removed.
Design performance
| Items | TerpSep™-A |
|---|---|
| IgG recovery [%] | 99 |
| IgG aggregate rejection [%] | 100 |
| Albumin adsorption [mg/ml-membrane volume] | 68 |
| DNA adsorption [mg/mL] | 12 |
Filtration mode: constant-flow dead-end filtration
Test solution: albumin 0.25 g/L (dissolved in tris-HCl buffer, pH 7.0)
■ TerpSep™-C
TerpSep™-C incorporates an anionic polymer uniformly throughout the membrane, facilitating the adsorption and effective capture of cationic components while preserving the size-based separation functionality.
Lysozyme adsorption
Cationic charged proteins can be adsorbed and removed.
Design performance
| Items | TerpSep™-C | |
|---|---|---|
| IgG recovery [%] | 99 | |
| IgG aggregate rejection [%] | 99 | |
| Lyz adsorption [mg/ml-membrane volume] | pH 7 | 45 |
Filtration mode: constant-flow dead-end filtration
Test solution: lysozyme 0.50 g/L (dissolved in phosphate buffer, pH 7.0)
Product Inquiries
Contact UsVirus removal membrane (TerpSep™-V)
Toyobo’s virus removal membrane, surface-modified with a specialized polymer from Otsuka Chemical, achieves high-throughput filtration while maintaining effective phage removal performance.
Performance Data
Membrane permeate flux
Filtration mode: constant-pressure dead-end filtration
Pressure: 200 kPa
Antibody concentration: 0.5 g/L
Buffer: phosphate buffer, pH 7.2
The liquid processing volume was approximately doubled compared to Toyobo’s conventional membrane.
Design performance
| Items | TerpSep™ | |||
|---|---|---|---|---|
| Throughput performance | Volume processed in 120 min (L/m²) | 195 | ||
| Phage removal (LRV) | pH dependence | pH 7 | ≧4.7 | |
| pH 5 | ≧4.7 | |||
| pH 4 | ≧4.7 | |||
| High phage concentration | ≧4.7 | |||
| TP | IgG concentration | 30 g/L | ≧4.7 | |
| 10 g/L | ≧4.7 | |||
| 5 g/L | ≧4.7 | |||
| High pressure | 300 kPa | ≧4.7 | ||
| 400 kPa | ≧4.7 | |||
Bacteriophage removal performance
Operating conditions
Filtration mode: constant-pressure dead-end filtration
Pressure: 200 kPa
Test solution: IVIG, 0.5 g/L (diluted with phosphate buffer, pH 7.2)
Spiked phage: PP7 bacteriophage, 10⁷ pfu/mL
pH dependence
TerpSep™-V (●) maintained an LRV of 4.0 or higher under all pH conditions tested.
The synthetic polymer flat-sheet membrane (■) was tested only at pH 7.0, and the data overlap with TerpSep™-V (●).
Protein concentration dependence
TerpSep™-V (●) maintained an LRV of 4.0 or higher under all protein concentration conditions tested.
The synthetic polymer flat-sheet membrane (■) was tested only at a protein concentration of 30 g/L, and the data overlap with TerpSep™-V (●).
Pressure dependence
TerpSep™-V (●) maintained an LRV of 4.0 or higher under all operating pressure conditions tested.
The synthetic polymer flat-sheet membrane (■) was tested only at 0.40 MPa, and the data overlap with TerpSep™-V (●).
TerpSep™-V: Virus clearance test
An MVM-spiked IVIG solution was subjected to dead-end filtration using TerpSep™-V.
Operating conditions
- Pressure: 200 kPa±10 kPa
- Number of replicates N=2
- Test solution: IVIG, 0.5 g/L
Challenge virus: MVM (18–26 nm)
Virus spike ratio: 1%
Buffer: phosphate buffer, pH 7.2
Test illustration
Results
| LRV | |
|---|---|
| Filtration test (1) | ≧5.0 |
| Filtration test (2) | ≧5.0 |
TerpSep™-V: Dead-end filtration test for gold nanoparticles
A filtration test was conducted using TerpSep™-V on a mixture of gold nanoparticle suspension and protein solution.
Operating conditions
- Flow rate: 0.5 mL/min
- Test solution:
Protein: molecular weight 150–160 kDa (yellow)
Gold nanoparticles: 30 nm (red)
Results
TerpSep™-V facilitated the selective separation of proteins, the target component.
Product specifications
| Items | Specifications |
|---|---|
| Membrane material | Hydrophilic polyether sulfone |
| Membrane type | Hollow fiber membrane |
| Supply form | Dry |
| Nominal pore size (nm) | 20 *Adjustable |
Module size lineup
*The data shown are from measurements taken under standard conditions and do not constitute guaranteed values. Results obtained under actual usage conditions may differ.